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Clinical Trials for Melanoma: Your Input Needed
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Clinical Trials for Melanoma: Your Input Needed

› Forums › General Melanoma Community › Clinical Trials for Melanoma: Your Input Needed

  • Post
    • January 26, 2013 at 3:29 pm
    alankravitz
    Participant

      I am a Stage IV melaonoma survivor and melanoma activist. I have been invited to participate in the Patient-Centered Clinical Trial Summit at the Partnership in Clinical Trials Conference. This gives me a unique opportunity to present a patient perspective to key stakeholders in Pharma, the CRO industry and the regulatory community. I am looking for additional patient input concerning the design, conduct, financing and analysis of clinical trials as well as the regulatory process.

      I am a Stage IV melaonoma survivor and melanoma activist. I have been invited to participate in the Patient-Centered Clinical Trial Summit at the Partnership in Clinical Trials Conference. This gives me a unique opportunity to present a patient perspective to key stakeholders in Pharma, the CRO industry and the regulatory community. I am looking for additional patient input concerning the design, conduct, financing and analysis of clinical trials as well as the regulatory process.

      The entire Translational Research Model in the US and internationally is under scrutiny by groups at home and abroad. ( see for example: the Conference on Clinical Care Research sponsored by the Friends of Cancer Research in November of 2012). We are close to significant changes in how our FDA will regulate Breakthrough Therapies under PDFUA 5. However, the international picture is not as good: requirements for approval such as  endpoint selection, randomization, comparator arms, use of placebos, and etc. are all based on antiquated notions of what constiutes scientific proof. They treat all diseases alike, they were designed to evaluate synthetic chemical treatments. They do not recognize that critical diseases like metastatic melanoma require a different approach to clinical trials because too many people are dying and because new targeted and immunologic therapies may not yet cure but have higher response rates, more durable responses, more tolerability and more practical benefits than the Starndard of Care. With the globalization of the pharmeceutical marketplace and the globilization of clinical trials to reduce costs and problems of patient recruitment, the problem of  differential standards has been exacerbated. I intend to use as an example the recently announced BMS Phase 3 trial NCT01721772) of anti-PD-1 (BMS-036558). It is the breakthrough therapy that saved my life (Extended 1B Trial) and an excellent example of the need to change regulatory practices and trial design now. As I am fond of saying , we need anti-PD-1 and we need it now!  If we want participatory medicine, we must participate not only at the level of personal choice but at the policy level.

      As I prepare my thoughts, I need to know yours. You may respond here or to me directly at [email protected] if you desire your comments to be kept private.

      Alan

    Viewing 5 reply threads
    • Replies
        • January 26, 2013 at 4:10 pm
        lou2
        Participant

          Being new to melanoma, I don't have anything very useful to suggest.  Hopefully others will. This is important.  Thank you for doing it.

          But I do have a question that comes out of my experience with other clinical research, and that has do with who will be attending this meeting.  Funding agencies such as NIH did not seem to be on your list of attendees, or maybe they were included in "regulatory agencies?"

          Here is a link that has a section on who funds clinical research:

          http://www.centerwatch.com/clinical-trials/overview.aspx

          NIH trials on melanoma:

          http://bethesdatrials.cancer.gov/melanoma/index.aspx

          Even if NIH does not currently have a lot of trials in this area, they are the chief public funder of research in this country, so having input there is important.  Maybe that is a separate area from what you are doing now?

           

          • January 26, 2013 at 4:10 pm
          lou2
          Participant

            Being new to melanoma, I don't have anything very useful to suggest.  Hopefully others will. This is important.  Thank you for doing it.

            But I do have a question that comes out of my experience with other clinical research, and that has do with who will be attending this meeting.  Funding agencies such as NIH did not seem to be on your list of attendees, or maybe they were included in "regulatory agencies?"

            Here is a link that has a section on who funds clinical research:

            http://www.centerwatch.com/clinical-trials/overview.aspx

            NIH trials on melanoma:

            http://bethesdatrials.cancer.gov/melanoma/index.aspx

            Even if NIH does not currently have a lot of trials in this area, they are the chief public funder of research in this country, so having input there is important.  Maybe that is a separate area from what you are doing now?

             

            • January 26, 2013 at 4:10 pm
            lou2
            Participant

              Being new to melanoma, I don't have anything very useful to suggest.  Hopefully others will. This is important.  Thank you for doing it.

              But I do have a question that comes out of my experience with other clinical research, and that has do with who will be attending this meeting.  Funding agencies such as NIH did not seem to be on your list of attendees, or maybe they were included in "regulatory agencies?"

              Here is a link that has a section on who funds clinical research:

              http://www.centerwatch.com/clinical-trials/overview.aspx

              NIH trials on melanoma:

              http://bethesdatrials.cancer.gov/melanoma/index.aspx

              Even if NIH does not currently have a lot of trials in this area, they are the chief public funder of research in this country, so having input there is important.  Maybe that is a separate area from what you are doing now?

               

              • January 26, 2013 at 4:50 pm
              aldakota22
              Participant

                Yes you are so right on many points.The old way of doing buisness is no longer efficient.With a global approach to research and trials  a  more  joint effort by all parties involved is needed.People can not wait  to get life saving drugs.Timei s something we they can ill afford to waste.Everyday that potential breakthrough is held up  someone  needlessly dies.They can"t wait till tomorrow when they need answers yesterday.Beat the Beast.   Al

                • January 26, 2013 at 4:50 pm
                aldakota22
                Participant

                  Yes you are so right on many points.The old way of doing buisness is no longer efficient.With a global approach to research and trials  a  more  joint effort by all parties involved is needed.People can not wait  to get life saving drugs.Timei s something we they can ill afford to waste.Everyday that potential breakthrough is held up  someone  needlessly dies.They can"t wait till tomorrow when they need answers yesterday.Beat the Beast.   Al

                  • January 26, 2013 at 4:50 pm
                  aldakota22
                  Participant

                    Yes you are so right on many points.The old way of doing buisness is no longer efficient.With a global approach to research and trials  a  more  joint effort by all parties involved is needed.People can not wait  to get life saving drugs.Timei s something we they can ill afford to waste.Everyday that potential breakthrough is held up  someone  needlessly dies.They can"t wait till tomorrow when they need answers yesterday.Beat the Beast.   Al

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